MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC TRIFURCATED MONITORING KIT W/SAFESET RESERVOIR AND BLOOD SAMPLING PORT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 426500406

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been received.Testing is not complete.

Event Description

User facility medwatch was received that stated the following: ¿upon pulling a blood sample from the integrated syringe plunger, a specimen was unable to be pulled and blood leaked out behind the syringe plunger and out the plunger hole onto the user¿s hands.The black rubber piece was able to be attached back to the plunger." there was unknown patient involvement, unknown human harm or adverse event, and unknown delay in critical therapy.No additional information received.

Manufacturer Narrative

One (1) used, partial set, transpac trifurcated monitoring kit with safeset reservoir and 2 blood sampling ports, list # 426500406, was received for investigation.The plunger tip of the safeset reservoir was separated and unable to be pulled back.The probable cause was due to the clips not being fully inserted (engaged) into the mating component during the manufacturing process.The reported complaint of the broken plunger was confirmed.The dhr for lot # 3748023 and relevant commodities were reviewed and no non-conformances were noted that would have contributed to the reported complaint.

• Brand Name: TRANSPAC TRIFURCATED MONITORING KIT W/SAFESET RESERVOIR AND BLOOD SAMPLING PORT
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8170916
• MDR Text Key: 131148002
• Report Number: 9617594-2018-00225
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619045029
• UDI-Public: (01)00840619045029(17)210701(10)3748023
• Combination Product (y/n): N
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 426500406
• Device Lot Number: 3748023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1